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TESARO Inc (TSRO.OQ)

TSRO.OQ on NASDAQ Stock Exchange Global Select Market

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24 Mar 2017
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Latest Key Developments (Source: Significant Developments)

Tesaro reports Niraparib phase 3 ENGOT-OV16/NOVA trial secondary endpoint results
Monday, 13 Mar 2017 11:10am EDT 

Tesaro Inc : Tesaro announces presentation of niraparib phase 3 ENGOT-OV16/NOVA trial secondary endpoint results during SGO . Niraparib had no impact on efficacy of next-line therapy . Niraparib significantly improved chemotherapy-free interval among patients who were germline brca mutation carriers . PFS-2 data were statistically significant and favored Niraparib over control for patients in both gbrcamut cohort, non-gbrcamut cohort . Progression-free surivival-2 and overall survival are immature, but favor Niraparib .Among patients without Germline BRCA mutations, Niraparib arm successfully achieved statistical significance over control arm for secondary endpoint of CFI.  Full Article

Tesaro Q4 loss per share $2.60
Tuesday, 28 Feb 2017 04:05pm EST 

Tesaro Inc : Tesaro announces fourth-quarter 2016 operating results . Q4 loss per share $2.60 . Q4 revenue $4.2 million versus $200,000 . Q4 revenue view $5.8 million -- Thomson Reuters I/B/E/S .Q4 earnings per share view $-1.95 -- Thomson Reuters I/B/E/S.  Full Article

Tesaro expects to have sold about 9,165 Varubi units in quarter ended Dec. 31
Monday, 9 Jan 2017 09:00am EST 

Tesaro Inc :Sees total number of units of Varubi sold by company in quarter ended December 31, 2016 were approximately 9,165 units.  Full Article

Tesaro announces priority review designation for niraparib nda
Tuesday, 20 Dec 2016 08:00am EST 

Tesaro Inc : Tesaro announces priority review designation for Niraparib NDA . FDA has established a target action date under prescription drug user fee act of June 30, 2017 .An expanded access program (EAP) for Niraparib in United States is planned to open in January 2017.  Full Article

Tesaro announces pricing of public offering of common stock
Tuesday, 15 Nov 2016 09:30am EST 

Tesaro Inc : Priced an underwritten public offering of an aggregate of 1.75 million shares of common stock at offering price to public of $135.00/share .Tesaro announces pricing of public offering of common stock.  Full Article

Tesaro announces third-quarter 2016 operating results
Thursday, 3 Nov 2016 04:05pm EDT 

Tesaro Inc : Tesaro Inc says pre-launch planning ongoing to support four potential product launches in 2017 across U.S. and Europe . Tesaro announces third-quarter 2016 operating results . Q3 loss per share $1.98 .Q3 earnings per share view $-1.92 -- Thomson Reuters I/B/E/S.  Full Article

Tesaro announces acceptance for review of niraparib Marketing Authorization Application by EMA
Thursday, 27 Oct 2016 04:05pm EDT 

Tesaro Inc : Tesaro announces acceptance for review of niraparib Marketing Authorization Application by Ema . Tesaro inc says with this acceptance, review of niraparib Marketing Authorisation Application in centralised procedure will now begin .Well positioned for two potential product launches in EUROPE in 2017.  Full Article

Tesaro says MAA for niraparib submitted for review by EMA
Thursday, 27 Oct 2016 04:05pm EDT 

Tesaro Inc :Marketing Authorisation Application (MAA) for niraparib has been submitted to and accepted for review by European Medicines Agency.  Full Article

Tesaro and Zai Lab announce collaboration, development and license agreement
Thursday, 29 Sep 2016 07:01am EDT 

Tesaro Inc: Tesaro and zai lab announce collaboration, development and license agreement . Tesaro has granted to Zai Lab an exclusive license for development of niraparib specifically for china market . Tesaro retains right to co-market in China and receives option to license up to two novel immuno-oncology programs outside China . Companies will establish a joint steering committee to review and oversee all development and commercialization plans . Tesaro will be eligible to receive milestone payments contingent upon Zai Lab achieving certain specified development and commercial goals . Initiated a rolling submission of a new drug application (NDA) for niraparib to FDA, and intends to complete this submission during Q4 . Should co elect not to participate in commercialization of niraparib in china,co willreceive royalty payments on annual net sales from Zai Lab . Tesaro has option to license two novel, discovery-stage immuno-oncology programs from Zai Lab . Additional financial details were not disclosed .Marketing authorization application (MAA) for niraparib is planned for submission to european medicines agency (EMA) in Q4.  Full Article

Tesaro Q2 loss per share $1.28
Thursday, 4 Aug 2016 04:30pm EDT 

Tesaro Inc :Q2 loss per share $1.28.  Full Article

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BRIEF-Tesaro reports Niraparib phase 3 ENGOT-OV16/NOVA trial secondary endpoint results

* Tesaro announces presentation of niraparib phase 3 ENGOT-OV16/NOVA trial secondary endpoint results during SGO